MRF-Guided Surgery for Brain Tumors

Overseen By Chaitra Badve, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Prior glioblastoma treatment, Recurrent glioma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

114 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MRF/MRI infiltration guidance for extended resection in brain tumors?

Research shows that using MRI guidance during brain tumor surgery helps surgeons remove more of the tumor compared to traditional methods. This approach has been linked to longer survival times for patients and low surgical complications. ^{1 2 3 4 5}

Is MRF-Guided Surgery for Brain Tumors safe for humans?

Research shows that using functional MRI (fMRI) before brain tumor surgery can reduce the risk of complications after surgery. Studies found that patients who had fMRI mapping before surgery had fewer adverse events compared to those who did not, suggesting it is generally safe when used properly. ^{5 6 7 8 9}

How is MRF/MRI-guided surgery for brain tumors different from other treatments?

MRF/MRI-guided surgery for brain tumors is unique because it uses real-time imaging to guide the surgeon during the operation, allowing for more precise removal of the tumor. This method helps in distinguishing tumor boundaries that are not visible to the naked eye, potentially leading to more complete tumor removal and improved patient outcomes compared to traditional surgical techniques. ^{2 3 4 10 11}

What is the purpose of this trial?

Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.

Research Team

Tiffany Hodges, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Chaitra A Badve, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with glioblastoma, a type of brain tumor. Participants should be eligible for neurosurgical resection, the surgical removal of part of the brain to treat their condition.

Inclusion Criteria

Ability to provide written informed consent

I am older than 18.

MR imaging findings suggestive of GB

Exclusion Criteria

I cannot undergo surgery due to health risks.

Contraindications to MRI

I had a minor surgery or biopsy for my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgical resection of glioblastomas with or without advanced MRI and MRF analysis guidance

1 day

1 visit (in-person)

Immediate Post-Surgery Monitoring

Participants are monitored for serious adverse events 48 hours post-surgery

48 hours

Short-term Follow-up

Participants are monitored for serious adverse events 30 days post-surgery

30 days

Long-term Follow-up

Participants are monitored for progression-free survival and recurrence

12 months

Treatment Details

Interventions

• MRF/MRI infiltration guidance for extended resection

Trial Overview The study is testing if Magnetic Resonance Fingerprinting (MRF) can better guide surgeons in removing more of the brain tumor than standard MRI techniques during surgery.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

The surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools.

Group II: Group 1 Experimental Treatment 1 Intervention

Routine standard of care process will be followed for neurosurgical guidance

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

Intraoperative magnetic resonance (MR) imaging significantly aided in achieving complete tumor resection, with 80% of patients showing radiologically complete resections based on intraoperative findings.

The use of MR imaging during surgery was safe, with a low frequency of complications and no adverse effects related to the MR environment, highlighting its potential benefits in brain tumor surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain tumor resection: intraoperative monitoring with high-field-strength MR imaging-initial results. Martin, AJ., Hall, WA., Liu, H., et al.[2004]

References

1. China pubmed.ncbi.nlm.nih.gov

[Integrating functional magnetic resonance imaging in neuronavigation surgery of brain tumors involving motor cortex]. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Intraoperative MRI to guide the resection of primary supratentorial glioblastoma multiforme--a quantitative radiological analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of the combination of 5-aminolevulinic acid-induced fluorescence with intraoperative magnetic resonance imaging-guided surgery for glioma. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing brain tumor resection. Low-field interventional MR imaging. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Application Value of Magnetic Resonance Imaging Medical Technology in the Perioperative Management of Brain Gliomas: Impact on Anesthesia and Prognosis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Brain tumor resection: intraoperative monitoring with high-field-strength MR imaging-initial results. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Can Preoperative Mapping with Functional MRI Reduce Morbidity in Brain Tumor Resection? A Systematic Review and Meta-Analysis of 68 Observational Studies. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging-guided brain tumor resection. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Intraoperative visualization of residual tumor: the role of perfusion-weighted imaging in a high-field intraoperative magnetic resonance scanner. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Intraoperative magnetic resonance imaging and magnetic resonance imaging-guided therapy for brain tumors. [2019]